cardiovascular disease
Conditions
Interventions
test:Bisoprolol fumarate tablet
reference:bisoprolol(Merck KGaA)
Sponsors
Chengdu Easton Biopharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subject; 2. Healthy subject with age 18~45 years old; 3. BMI in range of 19~26kg/m2 [BMI=weight (kg)/height 2(m2)] 4. Subject with normal physical examination. There is no medical history of heart, liver, kidney, digestive tract, nervous system, mental disorders and metabolic abnormalities. Blood and urine routine, liver and kidney function, blood lipid, and blood sugar are normal, urine pregnancy test negative in female subjects; 5. Subject should have a strong understanding of the object and require of trial, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Vital signs, physical examination and lab tests abnormal with clinical significance. 2. Allergic history for ingredients of investigator product, allergic disease, or allergic constitution; 3.Any history of cardiovascular system(such as cardiogenic shock, atrioventricular block and so on), or medical history of respiratory disease, or orthostatic hypotension, or halo needle or halo history of blood; 4. History of tobacco, alcohol or drug abuse history; 5. Used any medicine in the last 14 days. 6. Participated other clinical trial in the last 3 months; 7. Blood donation or test blood donation in the last 3 months. Planned blood donation during the trial or within 3 months after the trial. 8.Subject who has a birth plan or whose spouse has a childbirth program within three months. 9.Subject who has special diet requirements can not comply with the unified diet; 10.The investigators concluded that subjects had other factors that were not appropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC 0-8; | — |
Countries
China
Contacts
Public ContactPing Feng
West China Hospital, Sichuan University
Outcome results
None listed